Hypure Oil Heavy 100mL

FDA UDI

Class II (US FDA UDI)

by Kitazato Corporation

Identity

Trade Name: Hypure Oil Heavy 100mL FDA UDI
Generic Name: IVF medium kit FDA UDI
Model / Reference: MOHVUS-100 FDA UDI

Identifiers

Catalog Number: 93628 FDA UDI
Primary DI / UDI-DI: 04573316381379 FDA UDI
510(k) Number: K160142 FDA UDI
FDA Product Code: MQL FDA UDI
GMDN Term: IVF medium kit FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 884.6180 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: IVF medium kit

Hypure Oil Heavy 100mL by Kitazato Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as IVF medium kit.

Vit Kit - Freeze NX — FUJIFILM IRVINE SCIENTIFIC, INC. · Class II
G-Vitri™ Warming media — Gimbo Medical Technology Shenzhen Co., Ltd. · Class II
ORIGIO Gradient 40/80 — Origio A/S · Class II
G-Vitri™ Warming media — Gimbo Medical Technology Shenzhen Co., Ltd. · Class II
G-Vitri™ Vitrification media — Gimbo Medical Technology Shenzhen Co., Ltd. · Class II
MC Vitrification Cooling — Origio A/S · Class II
ViaBL™ Super-Fast Blastocyst Warming Kit — CooperSurgical, Inc. · Class II
BlastThaw — Origio A/S · Class II

Cleared under the same submission

K160142 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Kitazato Corporation

Sources (1)

FDA UDI ef938bde-cd6c-44b2-9d18-32c866ce82df 35 fields · synced Jun 8, 2026